Closure device with fixed jaw hook

ABSTRACT

A device includes a capsule extending longitudinally from a proximal end to a distal end and including a channel extending therethrough. The capsule is releasably coupled to a proximal portion of the device. Device also includes a first arm rigidly fixed to the distal end of the capsule to extend distally therefrom. In addition, Device includes a second arm, a proximal end of which is slidably received within the capsule so that the second arm is movable between an open configuration, in which the second arm is moved laterally away from the first arm and a distal end of the second arm is moved distally past the distal end of the first arm, and a closed configuration, in which the second arm is moved toward the first arm and the distal end of the second arm is moved proximally toward the distal end of the first arm.

The present application is a Continuation of pending U.S. patentapplication Ser. No. 15/589,620 filed May 8, 2017, which claims priorityto U.S. Provisional Patent Application Ser. No. 62/333,615 filed May 9,2016; the disclosure of which is incorporated herewith by reference.

BACKGROUND

Physicians have become more willing to perform more aggressiveinterventional and therapeutic endoscopic procedures including, forexample, removal of larger lesions (e.g., cancerous masses), tunnelingunder mucosal layers in the gastro-intestinal (GI) tract to treattissues below the mucosa, full thickness removal of tissue, insertingdevices through the GI tract and then penetrating the GI organ to treattissue outside the GI tract, and endoscopic treatment/repair ofpost-surgical issues (e.g., post-surgical leaks, breakdown of surgicalstaple lines, anastomotic leaks). These procedures may increase the riskof perforating or damaging the wall of the GI tract, or may requireclosure of the GI tract wall as part of the procedure. Endoscopicclosure can reduce the cost, trauma and inconvenience associated withthese procedures. However, conventional endoscopic tissue closuredevices may be insufficient to close certain tissue defects.

SUMMARY

The present invention is directed to a device for treating a tissuecomprising a capsule extending longitudinally from a proximal end to adistal end and including a channel extending therethrough, the capsulereleasably coupled to a proximal portion of the device and a first armrigidly fixed to the distal end of the capsule to extend distallytherefrom in combination with a second arm, a proximal end of which isslidably received within the capsule so that the second arm is movablebetween an open configuration, in which the second arm is movedlaterally away from the first arm and a distal end of the second arm ismoved distally past the distal end of the first arm, and a closedconfiguration, in which the second arm is moved toward the first arm andthe distal end of the second arm is moved proximally toward the distalend of the first arm.

In an embodiment, the first arm extends along an axis substantiallyparallel to a longitudinal axis of the capsule.

In an embodiment, the distal end of the first arm includes a tissuepiercing member extending laterally inward toward the second arm.

In an embodiment, the second arm is biased toward the open configurationand is restrained via an interior surface of the capsule in the closedconfiguration.

In an embodiment, the second arm is formed of a compliant material.

In an embodiment, the compliant material includes one of Nitinol andStainless Steel.

In an embodiment, an interior surface of one of the first and secondarms include a hook, undercut and barb for catching a target tissue.

In an embodiment, an interior surface of the first arm is curved so thatlongitudinal edges thereof extend toward the second arm to form a cuppedtissue receiving pocket.

In an embodiment, the first arm includes a broad interior surfaceforming a tissue receiving pocket in one plane.

In an embodiment, the interior surface includes one of teeth, spikes,grooves and a textured surface to grip tissue received between the firstand second anus.

The present disclosure also relates to a method for forming asuperelastic Nitinol arm for a tissue clipping device comprising:inserting Nitinol stock in a recess of a female portion of a dieassembly, the recess sized and shaped to have a desired geometry of thearm for the tissue clipping device; mating a male portion of the dieassembly to the female portion, the male portion including ageometrically complementary protrusion sized and shaped to be receivedwithin the recess of the female portion to configure the Nitinol stockto have the desired geometry of the arm; placing the mated male andfemale portions of the die assembly in a fluidic bath having atemperature of approximately 500° to treat the Nitinol stock having thedesired geometry; and removing the die assembly from the fluidic bathand water quenching the die assembly to set the Nitinol stock in thedesired geometry.

In an embodiment, the die assembly is removed from the fluidic bath andwater quenched once the Nitinol stock reaches 500° C.

In an embodiment, water quenching cools the Nitinol stock to roomtemperature.

In an embodiment, the recess of the female portion includes a curvedportion to form a corresponding curve in the arm.

In an embodiment, the protrusion of the male portion includes a portionfor stamping out a desired feature in the arm.

The present disclosure also relates to a method for treating a tissuedefect, comprising: inserting a clipping device, in a closedconfiguration, to a target area within a living body via a workingchannel of an endoscope, the clipping device including a capsule, afirst arm rigidly fixed to a distal end of the capsule and extendingdistally therefrom and a second arm movably received within the capsule;moving the clipping device from the closed configuration to an openconfiguration, in which the second arm is moved laterally away from thefirst arm and a distal end of the second arm is moved distally past adistal end of the first arm; piercing a first tissue along a first sideof a tissue defect with the distal end of the first arm; moving theclipping device toward a second tissue along a second side of the tissuedefect, the second side opposing the first side; grasping the secondtissue with the distal end of the second arm; and moving the clippingdevice toward the closed configuration, in which the second arm is drawnlaterally toward the first arm and the distal end of the second arm isdrawn proximally toward the distal end of the first arm so that thesecond tissue is drawn toward the first tissue, thereby closing thetissue defect.

In an embodiment, the clipping device is moved toward the closedconfiguration prior to moving the clipping device toward the secondtissue and is moved toward the open configuration prior to grasping thesecond tissue.

In an embodiment, the method includes locking the clipping device in theclosed configuration and deploying the clipping device.

In an embodiment, the clipping device is moved between the open andclosed configurations via a control element releasably coupled to theproximal end of the second arm, the control element being released fromthe second arm to deploy the clipping device.

In an embodiment, in the closed configuration, the distal ends of thefirst and second arms are substantially longitudinally aligned.

BRIEF DESCRIPTION

FIG. 1 shows a longitudinal side view of a device according to a firstexemplary embodiment of the present disclosure, in an openconfiguration;

FIG. 2 shows a longitudinal side view of the device of FIG. 1, in aclosed configuration;

FIG. 3 shows a longitudinal side view of a portion of an arm of thedevice of FIG. 1;

FIG. 4 shows another longitudinal side view of a portion of an arm ofthe device of FIG. 1;

FIG. 5 shows a front view of the portion of the arm of the device ofFIG. 4, from a distal end thereof;

FIG. 6 shows a side view of the device of FIG. 1, inserted to a targettissue in the closed configuration;

FIG. 7 shows a side view of the device of FIG. 1, a first arm of thedevice gripping a first side of a tissue defect in the openconfiguration;

FIG. 8 shows a side view of the device of FIG. 1, a second arm of thedevice gripping a second side of a tissue defect in the openconfiguration;

FIG. 9 shows a side view of the device of FIG. 1, moved to the closedconfiguration to close the tissue defect;

FIG. 10 shows a perspective view of a device according to an alternateembodiment of the present disclosure;

FIG. 11 shows a perspective view of a device according to anotheralternate embodiment of the present disclosure;

FIG. 12 shows a perspective view of an arm of the device of FIG. 1;

FIG. 13 shows a perspective view of a die assembly according to anexemplary embodiment of the present disclosure;

FIG. 14 shows a side view of the die assembly of FIG. 13; and

FIG. 15 shows a perspective view of a female die of the die assembly ofFIG. 13.

DETAILED DESCRIPTION

The present disclosure may be further understood with reference to thefollowing description and the appended drawings, wherein like elementsare referred to with the same reference numerals. The present disclosureis directed to an endoscopic clipping device for treating tissueperforations, defects and/or bleeding. In particular, exemplaryembodiments of the present disclosure describe an endoscopic clipincluding a first jaw rigidly fixed to a capsule and a second jawslidably housed within the capsule to be moved between an openconfiguration and a closed configuration. In the open configuration, adistal end of the second jaw extends laterally away from and distallypast a distal end of the first jaw so that target tissue may be receivedtherebetween. In the closed configuration, the second jaw is retractedinto the capsule so that the second jaw is moved laterally inward andthe distal end of the second jaw is moved toward the distal end of thefirst jaw to grip the target tissue therebetween. It should be notedthat the terms “proximal” and “distal,” as used herein, are intended torefer to a direction toward (proximal) and away from (distal) a user ofthe device.

As shown in FIGS. 1-9, a clipping device 100 according to an exemplaryembodiment of the present disclosure comprises a clip 102 insertableinto a living body through, for example, a working channel of anendoscope to a target tissue to be treated. The clip 102 is releasablyconnected to a proximal portion that is sufficiently flexible to permitit to be passed through the endoscope even when the endoscope istraversing tortuous paths of the body—e.g., passing through the workingchannel of an endoscope inserted through a natural body lumen accessedvia a natural body orifice. For example, the proximal portion mayinclude a flexible member formed of a coil of wire or any othersuitable, flexible structure. As shown in FIGS. 1-2, the clip 102includes a first arm 104 rigidly fixed to a distal end 110 of a capsule108 and a second arm 106 slidably received within a longitudinal channel112 of the capsule 108. The clip 102 is movable between an openconfiguration, in which a distal end 114 of the second arm 106 extendslaterally away from and distally of a distal end 116 of the first arm104, and a closed configuration, in which the distal end 114 of thesecond arm 106 extends toward the first arm 104 so that the distal end114 of the second arm 106 is substantially longitudinally aligned withthe distal end 116 of the first arm 104. In use, as shown in FIGS. 6-9,the clip 102 is inserted to a target area of the living body and movedto the open configuration so that a first capture feature 118 of thefirst arm 104 captures a first portion of tissue along a first side of atissue defect to be treated. With the first portion of tissue capturedby the first arm 104, the clip 102 is moved toward a second side of thetissue defect so that a second capture feature 120 on the second arm 106may capture a second portion of tissue along the second side of thetissue defect. The clip 102 may then be moved toward the closedconfiguration so that the first and second portions of tissue are movedtoward one another to close the tissue defect. Since the clip 102 allowsfor approximation of the first and second sides of the tissue defect,the device 100 may be particularly suited to treat large tissueopenings/defects.

The capsule 108 extends longitudinally from a proximal end 122 to thedistal end 110 and includes the channel 112 extending longitudinallytherethrough. The proximal end 122 of the channel 112 is releasablycoupled to a flexible member (not shown) of the proximal portion of thedevice 100 so that the clip 102, including the capsule 108, may bedeployed therefrom to be implanted in the body. The capsule 108 may, forexample, be coupled to the flexible member via a bushing releasablycoupled to the capsule 108 via cantilever arms of the bushing that areto received within corresponding windows at the proximal end of thecapsule 108, substantially as described in U.S. Patent Appln. Pub. No.2014/0088616 to Clerc et al. and assigned to Boston Scientific ScimedInc. (“the '616 application”). The entire disclosure of the '616application is incorporated herein by reference. The cantilever arms ofthe bushing may, for example, be biased to disengage from the capsule108 but are held in position locked into the windows of the capsule by asupport structure which is disengaged from the bushing arms when acontrol element connected to a proximal end of the second arm 106 isseparated therefrom. The control element may be coupled to the secondarm 106 via a control member, as described in U.S. Patent Appln. Pub.No. 2014/0088616 or, in another embodiment, may be directly coupled tothe second arm 106. The control element may be separated from the secondarm 106 when the control element is drawn proximally relative to thecapsule 108 to exceed a predetermined load. When the control element isseparated from the second arm 106, in this embodiment a locking tab ofthe second arm 106 moves radially outward to engage a portion of thecapsule 108, thereby locking the clip 102 in the closed configuration.Although the above describes a specific mechanism for locking anddeploying the clip 102, the clip 102 may be deployed from the proximalportion of the device 100 and/or locked in the closed configuration viaany of a variety of known clip deployment and locking mechanisms.

The first arm 104 extends distally from the distal end 110 of thecapsule 108 to the distal end 116. The first arm 104 in this embodimentis integrally formed with the capsule 108. However, in an alternativeconfiguration, the first arm 104 may be rigidly fixed to the capsule 108via any known connection mechanism such as, for example, welding. In oneembodiment, the first arm 104 extends from the distal end 110 of thecapsule 108 along an axis substantially parallel to a longitudinal axisof the capsule 108. The first arm 104 extends from a proximal end 124connected to the capsule 108 to the distal end 116. The distal end 116may be curved or bent to include a distal tip 126 that extends laterallyinward toward the longitudinal axis of the clip 102 so that the distaltip 126 may hook or grip target tissue received between the first andsecond arms 104, 106. As shown in FIG. 3, the distal end 116 may alsoinclude the first capture feature 118 which may be configured as, forexample, an undercut along a side of the first arm 104 facing the secondarm 106. Alternatively, or in addition to the undercut, as shown inFIGS. 4-5, the first capture feature 118 may include a barb punched intothe first arm 104 to extend toward the second arm 106. The first capturefeature 118 may be configured as any of a variety of elements extendingfrom a side or interior surface 128 of the first arm 104 to face towardthe second arm 106.

In one embodiment, as shown in FIGS. 1-2, the interior surface of thefirst arm 104 may be cupped or curved so that longitudinal edges thereofare curved toward the second arm 106 forming a cupped pocket in whichtissue may be received. In another embodiment, as shown in FIG. 10, afirst arm 104′ may have a broad (non-cupped) interior surface 128′ whichforms a tissue receiving pocket in one plane. The interior surface 128′may include teeth, spikes, grooves and/or a textured surface to provideadditional gripping for tissue received between the first and secondarms. A distal end 116′ of the first arm 104′ may also include a hook orother tissue piercing member such as a sharp point or barb for hookingor gripping tissue.

A proximal end of the second arm 106 is slidably received within thechannel 112 of the capsule 108 so that the second arm 106 is movablerelative thereto between the open and closed configurations. Theproximal end of the second arm 106 may be connected to a control elementextending proximally therefrom through the capsule 108 and the proximalportion of the device 100 to be controlled by a user. The controlelement may be moved longitudinally relative to the device 100 to movethe clip 102 between the open and closed configurations. The second arm106 is formed of a compliant material which permits the second arm 106to be moved between the open and closed configurations. The second arm106 may be movable between the open and closed configuration via, forexample, a living hinge. In one embodiment, the second arm 106 may bebiased toward the open configuration so that, when the second arm 106 ismoved distally relative to the capsule 108, toward the openconfiguration, the second arm 106 reverts to the biased configurationand moves laterally away from the first arm 104 as the distal end 114 ofthe second arm 106 is moved distally past the distal end 116 of thefirst arm 104. In the closed configuration, the second arm 106 is drawnproximally into the channel 112 and restrained via an interior surfaceof the capsule 108 so that the second arm 106 is moved laterally towardthe first arm 104 as the distal end 114 of the second arm 106 is movedtoward the distal end 116 of the first arm 104. In one embodiment, thedistal ends 116, 114 of the first and second arms 104, 106,respectively, may be substantially longitudinally aligned in the closedconfiguration.

Similarly to the first arm 104, the distal end 114 of the second arm 106may be bent or curved inward to form a distal tip 130 which extendslaterally inward toward the longitudinal axis of the clip 102 so thatthe distal tip 130 hooks and/or grips tissue received between the firstand second arms 104, 106. The distal tip 130 may include the secondcapture feature 120 for gripping tissue such as, for example, a sharppoint or barb. Alternatively or, in addition to the tissue grippingfeatures at the distal tip 130, the distal end 114 of the second arm 106may include tissue gripping/capturing features such as an undercutand/or a barb, as described above in regard to the first arm 104, and asshown in FIGS. 3-5.

In one embodiment, the distal ends 116, 114 of the first and second arms104, 106, respectively, are substantially longitudinally aligned in theclosed configuration so that the distal tips 126, 130 are substantiallyaligned and face one another. In another embodiment, as shown in FIG.11, a distal tip 130″ of a second arm 106″ includes a window 132″extending therethrough for accommodating a distal tip 126″ of a firstarm 104″ therein. Thus, in the closed configuration, the distal tip 126″of the first arm 104″ is received within the window 132″ of the secondarm 106″, when gripping tissue. Alternatively, the second arm 106″ maybe permitted to be drawn proximally of the first arm 104″ so that adistal end 114″ of the second arm 106″ may be drawn proximally past adistal end 116″ of the first arm 104″.

As shown in FIGS. 6-9, an exemplary method utilizing the device 100comprises inserting the clip 102, in the closed configuration, to atarget area within a living body via, for example, a working channel ofan endoscope. As described above, the clip 102 is able to approximateseparated portions of tissue so that the clip 102 is particularly suitedfor treating large tissue defects. Once at the target area, as shown inFIG. 6, the clip 102 is moved to the open configuration and manipulatedso that the distal end 116 of the first arm 104 hooks or grips a firstportion of tissue along a first side of the tissue defect, as shown inFIG. 7. The first portion of tissue may be captured by the hook at thedistal tip 126 of the first arm 104 and/or the first capture feature 118which may include, for example, an undercut or barb. Once the firstportion of tissue has been captured by the first arm 104, the clip 102is moved toward a second portion of tissue along a second side of thetissue defect—e.g., opposite the first side. Prior to moving the clip102 toward the second portion of tissue, the clip 102 may be movedtoward the closed configuration. Thus, upon reaching the second portionof tissue, the clip 102 is returned to the open configuration so thatthe second arm 106 is moved laterally and distally relative to the firstarm 104 to hook and/or grip the second portion of tissue via the distalend 114 of the second arm 106, as shown in FIG. 8. The second portion oftissue may be captured by the distal tip 130 and/or the second capturefeature 120. The gripping features, as described with respect to FIGS.10 and 11, may be used to provide greater grippage of the first andsecond portions of tissue between the first and second arms 104, 106.

Once the second portion of tissue has been captured/hooked, the clip 102is moved to the closed configuration to draw the second arm 106 towardthe first arm 104. As described above, the second arm 106 is movedlaterally toward the first arm 104 as the distal end 114 of the secondarm 106 is moved toward the distal end 116 of the first arm 104, asshown in FIG. 9, thereby drawing the first and second portions of tissuecaptured via the distal ends 116, 114, respectively, toward one another.Thus, tissue along the first and second sides of the tissue defect aredrawn together to close the tissue defect. Once the tissue defect hasbeen closed, as desired, the clip 102 may be locked in the closedconfiguration and deployed to separate it from the proximal portion ofthe device 100, as would be understood by those skilled in the art. Forexample, the control element connected to the proximal end of the secondarm 106 may be drawn proximally relative to the capsule 108 until apredetermined threshold load is exceeded and the control element isseparated from the second arm 106. Separation of the control elementfrom the second arm 106 in this embodiment then allows a locking tab ofthe second arm 106 to engage the capsule 108, thereby locking the secondarm 106 relative thereto, in the closed configuration. Proximal motionof the control element also facilitates release of the capsule 108 fromthe proximal portion of the device 100, thereby releasing the clip 102so that it will remain in the body when the proximal portion of thedevice 100 is withdrawn from the body. The clip 102 will then besloughed off as the natural healing process progresses as would beunderstood by those skilled in the art.

As described above, the second arm 106 of the clip 102 may, for example,be formed of a compliant material such as, for example, Nitinol. In oneembodiment, the second arm 106, as shown in FIG. 12, may be formed via asuperelastic Nitinol forming process, which includes a die assembly 200,as shown in FIGS. 13-15, comprising a male die 202 and a female die 204that are created to configure the Nitinol in the desired geometry. Thedie assembly 200 potentially increases the precision of the feature setin the Nitinol material and allows multiple sheets of metal to be formedat once, thereby decreasing cost and increasing volume outputcapabilities. Unlike conventional Nitinol forming processes, the maleand female dies 202, 204 are not required to be attached to anymachinery such as, for example, a press. Rather, the male and femaledies 202, 204 may include mating features such as, for example, bolts orpins, which allow the dies 202, 204 to be joined together while housingthe Nitinol stock so that the Nitinol stock is configured to the desiredgeometry. The joined male and female dies 202, 204 with the configuredNitinol would then be placed in a fluidic bath set at approximately 500°C. to treat the Nitinol. For example, the Nitinol may be treated at atemperature of between 450 and 550 degrees C. for from 2 to 20 minutes.In one embodiment, after treating the Nitinol for approximately 10minutes at 55 degrees C., the die assembly 200 is removed from the bathand immediately water quenched so that the Nitinol material retains itsdesired shape. Water quenching ensures that the Nitinol components arecooled immediately to room temperature, thereby limiting the amount oftime in which the Nitinol components remain at high temperature.Ideally, the Nitinol components are cooled immediately after the Nitinolhas reached 500° C. Thus, although the above method describes treatingthe Nitinol for approximately 10 minutes, this time may vary dependingon the amount of time it takes to heat the Nitinol to 500° C.

To create the desired Nitinol component (e.g., the second arm 106 shownin FIG. 12), the die assembly 200 is created in 3D form so that complexgeometry features may be created in the Nitinol. For example, as shownin FIGS. 13 and 15, the female die 204 of the die assembly 200 includesa recess 206 sized and shaped to create the desired size and shape ofthe second arm 106. The recess 206 may include a curved portion 208along a portion of a length thereof to create a corresponding radii 138in the second arm 106, which biases the arm 106 toward the openconfiguration, as described above. The female die 204 may also includeopenings 210 for receiving mating features such as, for example, boltsor pins, for joining the male die 202 to the female die 204.

The male die 202, as shown in FIGS. 13 and 14, may include ageometrically complementary protrusion 212 sized and shaped to bereceived within the recess 206 of the female die 204 so that when themale and female dies 202, 204 are mated or joined to one another, theNitinol stock received within the recess 206 is molded to the desiredsize and shape of the second arm 106. For example, the protrusion mayinclude a first portion 214 sized and shaped to stamp out a shape 134(e.g., rectangular) of a length of the second arm 106 and a secondportion 216 protruding from the first portion 214 for adding a feature136 (e.g., opening) in the second arm 106.

Although the female and male dies 204, 202 are shown and described asincluding a single recess 206 and complementary protrusion 212,respectively, the die assembly 200 may be designed to include multiplerecesses 206 and protrusions 212 so that multiple arms 106 may be formedat a time, reducing cost while increasing volume output. In addition,although the male and female dies 202, 204 are described as includingparticular design features, the male and female dies 202, 204 mayinclude any of a variety of geometrical features designed to create adesired geometry of the second arm 106.

Variations may be made in the structure and methodology of the presentdisclosure, without departing from the spirit and the scope of thedisclosure. Thus, it is intended that the present disclosure cover themodifications and variations of this disclosure that may be contemplatedby a person of skill in the art.

1-35. (canceled)
 36. A device for treating a tissue, comprising: a capsule extending longitudinally from a proximal end to a distal end and including a channel extending therethrough, the capsule releasably coupled to a proximal portion of a flexible member; a first arm extending distally between a first arm proximal end rigidly coupled to the distal end of the capsule and a first arm distal end; and a second arm extending from a second arm proximal end to a second aria distal end, the second arm proximal end being slidably received within the capsule.
 37. The device of claim 36, wherein a length of the second arm is greater than a length of the first arm.
 38. The device of claim 36, wherein the second arm is movable between an open configuration, in which the second arm angles laterally away from the first arm and the second arm distal end is moved distally past the first arm distal end, and a closed configuration, in which contact between the capsule and the second arm draws the second arm toward the first arm and draws the second arm distal end proximally toward the first arm distal end.
 39. The device of claim 38, wherein the second arm is biased toward the open configuration.
 40. The device of claim 36, wherein the first arm extends along an axis substantially parallel to a longitudinal axis of the capsule.
 41. The device of claim 36, wherein the first arm distal end includes a tissue piercing member extending laterally inward toward the second arm.
 42. The device of claim 36, wherein the second arm is formed of a compliant material.
 43. The device of claim 42, wherein the compliant material includes one of Nitinol and Stainless Steel.
 44. The device of claim 36, wherein an interior surface of one of the first and second arms include a hook, undercut and barb for catching a target tissue.
 45. The device of claim 36, wherein an interior surface of the first arm is curved so that longitudinal edges thereof extend toward the second arm to form a cupped tissue receiving pocket.
 46. The device of claim 36, wherein the first arm includes a broad interior surface forming a tissue receiving pocket in one plane.
 47. The device of claim 46, wherein the interior surface includes one of teeth, spikes, grooves and a textured surface to grip tissue received between the first and second arms. 